Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study ID
NCT06310057
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    Tofacitinib (JAKi) is a targeted therapy option for patients with refractory ax-SpA.

Study Details

The goal of this clinical trial is to assess the efficacy of tofacitinib in refractory axial spodyloarthritis (ax-SpA) with dose escalation from 10mg to 15mg. Patients will start on 10mg and then divided into 2 groups (10 and 15) at 3rd month according to major improvement criteria. The main question\[s\] it aims to answer are: * Efficacy and safety of tofacitinib in different doses * If escalation of tofacitinib is justified if clinical criteria is not fulfilled at 10mg

Key Dates

Start date
Jan 1, 2022
Status verified
Mar 2024
Primary completion
Mar 1, 2024
Completion
Mar 1, 2024

Study Design

Enrollment
92 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib 10mg
    All patient that fulfill the inclusion ans exclusion criteria will start at 10mg tofacitinib.
  • Experimental: Tofacitinib 15 mg
    At 3rd month, patients that do not fulfill the ASDAS major improvement criteria will get 15mg tofacitinib.

Primary Outcome Measure

To assess the ASDAS CRP major improvement criteria in refractory ax-SpA patients with dose escalation from 10mg to 15mg [ Time Frame: 6 months ]

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